scholarly journals EPOC: Enfoque personalizado para el tratamiento según la guía GOLD 2021

2021 ◽  
pp. 1-2
Author(s):  
Moisés Acuña-Kaldman
Keyword(s):  
Airflow Obstruction ◽  
Dry Powder Inhaler ◽  
Phase Iii ◽  
Controlled Study ◽  
Blood Eosinophil ◽  
Severe Exacerbation ◽  
Airway Reversibility ◽  
Eosinophil Counts ◽  
Severe Copd ◽  
Formoterol Fumarate

<b>Background:</b> In the Phase III KRONOS study, triple therapy with budesonide/glycopyrronium/formoterol fumarate metered dose inhaler (BGF MDI) was shown to reduce exacerbations and improve lung function versus glycopyrronium/formoterol fumarate dihydrate (GFF) MDI in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). However, whether the benefits related to the ICS component of BGF are driven by patients with high blood eosinophil counts (EOS) and/or airway reversibility has not been previously studied. <b>Methods:</b> KRONOS was a Phase III, double-blind, parallel-group, multicenter, randomized, controlled study of patients with moderate-to-very-severe COPD. Patients were randomized 2:2:1:1 to receive BGF 320/14.4/10 μg, GFF 14.4/10 μg, budesonide/formoterol fumarate dihydrate (BFF) MDI 320/10 μg via a single Aerosphere inhaler, or open-label budesonide/formoterol fumarate dihydrate dry powder inhaler 400/12 μg (BUD/FORM DPI; Symbicort Turbuhaler) twice-daily for 24 weeks. Efficacy outcomes included in this post-hoc analysis were change from baseline in morning pre-dose trough FEV1 over weeks 12–24 and the rate of moderate-to-severe and severe COPD exacerbations. Adverse events in the non-reversible subgroup are also reported. <b>Results:</b> Of 1896 patients analyzed, 948 (50%) were non-reversible and had EOS &#x3c;300 cells/mm<sup>3</sup>. In this group, BGF significantly improved morning pre-dose trough FEV<sub>1</sub> versus BFF and BUD/FORM (least squares mean treatment difference, 95% confidence interval [CI] 69 mL [39, 99], unadjusted <i>p</i>  &#x3c; 0.0001 and 51 mL [20, 81], unadjusted <i>p</i> = 0.0011, respectively) and was comparable to GFF. BGF also significantly reduced annual moderate-to-severe exacerbation rates versus GFF (rate ratio [95% CI] 0.53 [0.37, 0.76], unadjusted <i>p</i> = 0.0005), with numerical reductions observed versus BFF and BUD/FORM. These results were similar for the overall study population. Safety findings were generally similar between non-reversible patients with EOS &#x3c;300 cells/mm<sup>3</sup> and the overall population. <b>Conclusions:</b> In patients with moderate-to-very-severe COPD without airway reversibility and EOS &#x3c;300 cells/mm<sup>3</sup>, BGF significantly improved morning pre-dose trough FEV1 versus BFF and BUD/FORM and significantly reduced the rate of moderate-to-severe exacerbations versus GFF. These findings demonstrate that BGF can provide benefits for a broad range of patients with COPD, and that the overall findings of the KRONOS primary analysis were not driven by patients with reversible airflow obstruction or high eosinophil counts. <b>Trial registration:</b> ClinicalTrials.gov, NCT02497001. Registered 14 July 2015, https://clinicaltrials.gov/ct2/show/NCT02497001

scholarly journals Efficacy of budesonide/glycopyrronium/formoterol metered dose inhaler in patients with COPD: post-hoc analysis from the KRONOS study excluding patients with airway reversibility and high eosinophil counts

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shigeo Muro ◽  
Hisatoshi Sugiura ◽  
Patrick Darken ◽  
Paul Dorinsky
Keyword(s):  
Phase Iii ◽  
Dose Inhaler ◽  
Metered Dose Inhaler ◽  
Post Hoc Analysis ◽  
Metered Dose ◽  
Post Hoc ◽  
Airway Reversibility ◽  
Eosinophil Counts ◽  
Severe Copd ◽  
Formoterol Fumarate

Abstract Background In the Phase III KRONOS study, triple therapy with budesonide/glycopyrronium/formoterol fumarate metered dose inhaler (BGF MDI) was shown to reduce exacerbations and improve lung function versus glycopyrronium/formoterol fumarate dihydrate (GFF) MDI in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). However, whether the benefits related to the ICS component of BGF are driven by patients with high blood eosinophil counts (EOS) and/or airway reversibility has not been previously studied. Methods KRONOS was a Phase III, double-blind, parallel-group, multicenter, randomized, controlled study of patients with moderate-to-very-severe COPD. Patients were randomized 2:2:1:1 to receive BGF 320/14.4/10 μg, GFF 14.4/10 μg, budesonide/formoterol fumarate dihydrate (BFF) MDI 320/10 μg via a single Aerosphere inhaler, or open-label budesonide/formoterol fumarate dihydrate dry powder inhaler 400/12 μg (BUD/FORM DPI; Symbicort Turbuhaler) twice-daily for 24 weeks. Efficacy outcomes included in this post-hoc analysis were change from baseline in morning pre-dose trough FEV1 over weeks 12–24 and the rate of moderate-to-severe and severe COPD exacerbations. Adverse events in the non-reversible subgroup are also reported. Results Of 1896 patients analyzed, 948 (50%) were non-reversible and had EOS < 300 cells/mm3. In this group, BGF significantly improved morning pre-dose trough FEV1 versus BFF and BUD/FORM (least squares mean treatment difference, 95% confidence interval [CI] 69 mL [39, 99], unadjusted p < 0.0001 and 51 mL [20, 81], unadjusted p = 0.0011, respectively) and was comparable to GFF. BGF also significantly reduced annual moderate-to-severe exacerbation rates versus GFF (rate ratio [95% CI] 0.53 [0.37, 0.76], unadjusted p = 0.0005), with numerical reductions observed versus BFF and BUD/FORM. These results were similar for the overall study population. Safety findings were generally similar between non-reversible patients with EOS < 300 cells/mm3 and the overall population. Conclusions In patients with moderate-to-very-severe COPD without airway reversibility and EOS < 300 cells/mm3, BGF significantly improved morning pre-dose trough FEV1 versus BFF and BUD/FORM and significantly reduced the rate of moderate-to-severe exacerbations versus GFF. These findings demonstrate that BGF can provide benefits for a broad range of patients with COPD, and that the overall findings of the KRONOS primary analysis were not driven by patients with reversible airflow obstruction or high eosinophil counts. Trial registration ClinicalTrials.gov, NCT02497001. Registered 14 July 2015, https://clinicaltrials.gov/ct2/show/NCT02497001

scholarly journals Prevalence and clinical implications of bronchiectasis in patients with overlapping asthma and chronic rhinosinusitis: a single-center prospective study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Haiyan Sheng ◽  
Xiujuan Yao ◽  
Xiangdong Wang ◽  
Yuhong Wang ◽  
Xiaofang Liu ◽  
...  
Keyword(s):  
Prospective Study ◽  
Chronic Rhinosinusitis ◽  
Peripheral Blood ◽  
Scoring System ◽  
Severe Disease ◽  
Airflow Obstruction ◽  
Blood Eosinophil ◽  
Severe Exacerbation ◽  
Peripheral Blood Eosinophil ◽  
Eosinophil Counts

Abstract Background As a typical “united airway” disease, asthma-chronic rhinosinusitis (CRS) overlap has recently drawn more attention. Bronchiectasis is a heterogeneous disease related to a variety of diseases. Whether bronchiectasis exists and correlates with asthma-CRS patients has not been fully elucidated. The purpose of the study was to explore the presence and characteristics of bronchiectasis in patients with overlapping asthma and CRS. Methods This report describes a prospective study with consecutive asthma-CRS patients. The diagnosis and severity of bronchiectasis were obtained by thorax high-resolution computed tomography (HRCT), the Smith radiology scale and the Bhalla scoring system. CRS severity was evaluated by paranasal sinus CT and the Lund-Mackay (LM) scoring system. The correlations between bronchiectasis and clinical data, fraction of exhaled nitric oxide, peripheral blood eosinophil counts and lung function were analyzed. Results Seventy-two (40.91%) of 176 asthma-CRS patients were diagnosed with bronchiectasis. Asthma-CRS patients with overlapping bronchiectasis had a higher incidence rate of nasal polyps (NPs) (P = 0.004), higher LM scores (P = 0.044), higher proportion of ≥ 1 severe exacerbation of asthma in the last 12 months (P = 0.003), lower postbronchodilator forced expiratory volume in one second (FEV1) % predicted (P = 0.006), and elevated peripheral blood eosinophil counts (P = 0.022). Smith and Bhalla scores were shown to correlate positively with NPs and negatively with FEV1% predicted and body mass index. Cutoff values of FEV1% predicted ≤ 71.40%, peripheral blood eosinophil counts > 0.60 × 109/L, presence of NPs, and ≥ 1 severe exacerbation of asthma in the last 12 months were shown to differentiate bronchiectasis in asthma-CRS patients. Conclusions Bronchiectasis commonly overlaps in asthma-CRS patients. The coexistence of bronchiectasis predicts a more severe disease subset in terms of asthma and CRS. We suggest that asthma-CRS patients with NPs, severe airflow obstruction, eosinophilic inflammation, and poor asthma control should receive HRCT for the early diagnosis of bronchiectasis.

scholarly journals Effect of Antiasthma Medication on Blood Eosinophil Count and Serum Immunoglobulin E Levels: A Randomized Controlled Study

2020 ◽  
pp. 33-39
Author(s):  
Wasim A. Wani ◽  
Sheeraz A. Dar ◽  
Khalid M. Kawosa ◽  
Mudasir Nazir ◽  
Ikhlas Ahmad ◽  
...  
Keyword(s):  
Eosinophil Count ◽  
Immunoglobulin E ◽  
Airflow Obstruction ◽  
Controlled Study ◽  
Blood Eosinophil ◽  
Blood Eosinophil Count ◽  
Serum Ige ◽  
Randomized Controlled ◽  
Chronic Inflammatory Condition ◽  
Eosinophil Counts

Background: Asthma is a chronic inflammatory condition of lung airways resulting in episodic airflow obstruction. Aims: The main objective of this study is to find the effect of antiasthma medication on serum IgE levels and blood eosinophil count. Study Design: This randomized controlled trial study was performed in children aged 6-15 years of age, with clinically stable and moderate persistent asthma. Results: The findings of this study indicate both group (Budesonide/formoterol group and budesonide group) patients experienced a significant decrease in serum IgE levels and blood eosinophil counts over the study period. However, the difference in two groups was not statistically significant. Conclusions: Inhaled steroids are effective in controlling systemic inflammation in asthma as evidenced by a decrease in IgE levels and eosinophil counts. However addition of LABA doesn’t have any additive effect.

scholarly journals Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler versus dual therapies in patients with COPD: a sub-study of the ETHOS trial

2021 ◽  
Vol 15 ◽  
pp. 175346662110343 ◽  
Author(s):  
Klaus F. Rabe ◽  
Fernando J. Martinez ◽  
Dave Singh ◽  
Roopa Trivedi ◽  
Martin Jenkins ◽  
...  
Keyword(s):  
Lung Function ◽  
Area Under The Curve ◽  
Forced Expiratory Volume ◽  
Phase Iii ◽  
Dose Inhaler ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Double Blind ◽  
Metered Dose ◽  
Formoterol Fumarate

Background: In the phase III, 52-week ETHOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF), at two inhaled corticosteroid dose levels, resulted in significantly lower moderate/severe exacerbation rates versus glycopyrrolate/formoterol fumarate (GFF) and budesonide/formoterol fumarate (BFF). Here, we report results from the ETHOS pulmonary function test (PFT) sub-study, which assessed lung function in a subset of ETHOS patients. Methods: ETHOS (NCT02465567) was a randomized, double-blind, multi-center, parallel-group study in patients with moderate to very severe COPD who had experienced ⩾1 moderate/severe exacerbation in the previous year. Patients received BGF 320/18/9.6 µg, BGF 160/18/9.6 μg, GFF 18/9.6 µg, or BFF 320/9.6 µg twice daily via a single metered dose Aerosphere inhaler for 52 weeks. A subset of patients participated in the 4-hour PFT sub-study; primary endpoints were change from baseline in morning pre-dose trough forced expiratory volume in one second (FEV1) versus GFF and FEV1 area under the curve from 0 to 4 hours (AUC0–4) versus BFF at week 24. Results: The PFT modified intent-to-treat population included 3088 patients (mean age 64.4 years; mean reversibility post-albuterol 16.7%; mean post-albuterol FEV1% predicted 42.8). BGF 320/18/9.6 µg and 160/18/9.6 µg significantly improved morning pre-dose trough FEV1 at week 24 versus GFF ( p ⩽ 0.0035 for both). Improvements in trough FEV1 were also observed at week 52 for BGF 320/18/9.6 µg and 160/18/9.6 µg versus GFF ( p ⩽ 0.0005 for both). For FEV1 AUC0–4 at week 24, BGF 320/18/9.6 µg and 160/18/9.6 µg showed significant improvements versus BFF ( p < 0.0001 for both). Improvements were maintained at week 52 ( p < 0.0001). Conclusions: BGF 320/18/9.6 µg and 160/18/9.6 µg significantly improved trough FEV1 versus GFF and FEV1 AUC0–4 versus BFF at week 24. The lung function benefits with both doses of BGF were maintained following 52 weeks of treatment. The reviews of this paper are available via the supplemental material section.

scholarly journals The effect of exacerbation history on outcomes in the IMPACT trial

2020 ◽  
Vol 55 (5) ◽  
pp. 1901921 ◽  
Author(s):  
David M.G. Halpin ◽  
Mark T. Dransfield ◽  
MeiLan K. Han ◽  
C. Elaine Jones ◽  
Sally Kilbride ◽  
...  
Keyword(s):  
Health Status ◽  
Lung Function ◽  
Triple Therapy ◽  
Blood Eosinophil ◽  
Severe Exacerbation ◽  
Double Blind ◽  
Exacerbation Rate ◽  
Population Comparisons ◽  
The Impact ◽  
Eosinophil Counts

IMPACT, a 52-week, randomised, double-blind trial, assessed the efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus FF/VI or UMEC/VI in patients with symptomatic COPD and a history of exacerbations.Subgroup analyses assessed whether the efficacy of FF/UMEC/VI versus FF/VI or UMEC/VI and UMEC/VI versus FF/VI varies according to prior exacerbation history, and the combined effects of exacerbation history and blood eosinophil counts. Three subgroups were defined: single moderate (1 moderate/no severe; n=3056 (30%)), frequent moderate (≥2 moderate/no severe; n=4628 (45%)) and severe (≥1 severe/any moderate; n=2671 (26%)). End-points included annual on-treatment moderate/severe exacerbation rate (pre-specified), lung function and health status (both post-hoc).Moderate/severe exacerbation rates (reduction % (95% CI)) were reduced in the FF/UMEC/VI group versus FF/VI (single moderate 20% (10–29), frequent moderate 11% (2–19), severe 17% (7–26)) and versus UMEC/VI (single moderate 18% (5–29), frequent moderate 29% (21–37), severe 26% (14–35)). Moderate/severe exacerbation rates were reduced in the FF/VI group versus UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate 2% (−12–18), frequent moderate 21% (11–29), severe 11% (−3–22)). Moderate/severe exacerbation rates were lower in the FF/VI group compared with UMEC/VI in patients with higher eosinophil counts. FF/UMEC/VI improved lung function and health status versus both dual therapies irrespective of exacerbation subgroup. UMEC/VI improved lung function versus FF/VI in all subgroups.Triple therapy was more effective than dual regardless of exacerbation history, consistent with results in the intent-to-treat population. Comparisons between dual therapies were influenced by prior exacerbation history and eosinophil counts.

scholarly journals Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study

2018 ◽  
Vol 52 (3) ◽  
pp. 1801334 ◽  
Author(s):  
Gary T. Ferguson ◽  
Alberto Papi ◽  
Antonio Anzueto ◽  
Edward M. Kerwin ◽  
Christy Cappelletti ◽  
...  
Keyword(s):  
Dry Powder Inhaler ◽  
Area Under The Curve ◽  
Forced Expiratory Volume ◽  
Phase Iii ◽  
Dose Inhaler ◽  
Chronic Obstructive ◽  
Open Label ◽  
Double Blind ◽  
Delivery Technology ◽  
Formoterol Fumarate

TELOS compared budesonide (BD)/formoterol fumarate dihydrate (FF) metered dose inhaler (BFF MDI), formulated using innovative co-suspension delivery technology that enables consistent aerosol performance, with its monocomponents and budesonide/formoterol fumarate dihydrate dry powder inhaler (DPI) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), without a requirement for an exacerbation history.In this phase III, double-blind, parallel-group, 24-week study (NCT02766608), patients were randomised to BFF MDI 320/10 µg (n=664), BFF MDI 160/10 µg (n=649), FF MDI 10 µg (n=648), BD MDI 320 µg (n=209) or open-label budesonide/formoterol DPI 400/12 µg (n=219). Primary end-points were change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV1) and FEV1 area under the curve from 0–4 h (AUC0–4). Time to first and rate of moderate/severe exacerbations were assessed.BFF MDI 320/10 µg improved pre-dose trough FEV1versus FF MDI (least squares mean (LSM) 39 mL; p=0.0018), and BFF MDI 320/10 µg and 160/10 µg improved FEV1 AUC0–4versus BD MDI (LSM 173 mL and 157 mL, respectively; both p<0.0001) at week 24. BFF MDI 320/10 µg and 160/10 µg improved time to first and rate of moderate/severe exacerbations versus FF MDI. Treatments were well tolerated, with pneumonia incidence ranging from 0.5–1.4%.BFF MDI improved lung function versus monocomponents and exacerbations versus FF MDI in patients with moderate to very severe COPD.

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